UMIN-CTR Clinical Trial

Basic information
Public title	A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Acronym	ACT-1 study
Scientific Title	A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Scientific Title:Acronym	ACT-1 study
Region	Japan

Condition
Condition	taxane-induced peripheral neurotoxicity
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in average pain intensity between baseline and week 16.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Acupuncture
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient with breast cancer who had received curative treatment more than 3 months ago 2) Received taxane. 3) Have "mild" or severer symptom in PRO-CTCAE item 39b 4) 18 years or older 5) ECOG PS 0 or 1
Key exclusion criteria	1)Patient with peripheral neuropathy by other than taxane 2)have distant metastases or local recurrence 3)have fibromyalgia, inflammatory joint disease, or phantom limb pain 4)undergoing chemotherapy 5)have mental illness 6)have severe comorbidities 7)being pregnant or breastfeeding 8)history of acupuncture for CIPN
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Eriko Middle name Last name Satomi
Organization	National Cancer Center Hospital
Division name	Department of Palliative Medicine
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	0335422511
Email	esatomi@ncc.go.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Ishiki
Organization	National Cancer Center Hospital
Division name	Department of Palliative Medicine
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	0335422511
Homepage URL
Email	hishiki@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospiatl Department of Palliative Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Institutional Review Board
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel	0335422511
Email	irst@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 27 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055222

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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